Surgical Technique

NO HOLETHREE HOLEMULTI HOLE

Polyup to 44mm heads

Design surgeon list

Smith & Nephew thanks the following surgeons for their participation as part of the R3™ system design team:

Robert Barrack, MDSt. Louis, Missouri

Robert Bourne, MDLondon Health Sciences CenterLondon, Ontario, Canada

Jonathan Garino, MDUniversity of Pennsylvania School of MedicinePhiladelphia, Pennsylvania

Wayne M. Goldstein, MDClinical Professor of OrthopaedicsUniversity of Illinois at ChicagoIllinois Bone and Joint InstituteChicago, Illinois

Richard Kyle, MDMinneapolis, Minnesota

Stephen J. McMahon, MB, BS, FRACS(Orth), FA(Orth)ASenior Lecturer Monash UniversityMalabar Orthopaedic ClinicMelbourne, Australia

John L. Masonis, MDOrthoCarolinaHip & Knee CenterCharlotte, North Carolina

Henrik Malchau, MDAssociate Professor, Harvard Medical SchoolCo-Director, The Harris Orthopaedic Biomechanics and Biomaterials LaboratoryMassachusetts General HospitalBoston, Massachusetts

Michael Ries, MDUniversity of CaliforniaSan Francisco, California

Cecil Rorabeck, MD Professor of Orthopaedic SurgeryUniversity of Western Ontario London, Ontario, Canada

Nota Bene: The technique description herein is made available to the healthcare professional to illustrate the authors’ suggested treatment for the uncomplicated procedure. In the final analysis, the preferred treatment is that which addresses the needs of the patient.

Short technique

1. Preoperative planning

2. Acetabular reaming

3. Acetabular trialing

4. Shell insertion

5. Acetabular screw insertion

6. Acetabular poly liner insertion

4

Preoperative X-Rays should include an A/P of the pelvis centered over the symphysis and an A/P and lateral of the affected hip.

Templating can be done on the affected side, but it is important that the contralateral hip also be templated to verify the size.

To ensure a congruent fit, the acetabular component should be medialized to the medial aspect of the acetabulum, as indicated by the teardrop.

The center of rotation also should be marked for subsequent reference.

Acetabular exposure

Complete exposure of the acetabulum is required, regardless of the type of approach. Use the approach with which you are most familiar and achieve the best surgical results.

First, resect the acetabular labrum and place a blunt retractor anteriorly.

After identifying the transverse acetabular ligament, place a blunt retractor around the inferior margin of the acetabulum.

Depending on the exposure, a third retractor can be placed posteriorly following the excision of the labrum.

Remove all overhanging soft tissue and osteophytes in order to visualize the entire acetabular socket.

The acetabulum should be medialized to restore the normal center of hip rotation.

Preoperative planning

Surgical tips:

• To minimize the need of assistance, each of the acetabular retractors can be tied directly to a Charnley retractor.

• Dividing the transverse acetabular ligament will allow reaming to begin inferiorly, preventing the tendency of the reamer to migrate superiorly.

• Removal of soft tissue and overhanging osteophytes from the foveal notch aids visualization of the quadralateral plate and the depth that the acetabulum should be reamed.

Select an acetabular reamer that is considerably smaller than the templated size of the cup. Generally, reaming 6-8mm lower than the templated size is suitable.

Position the initial reamer in a vertical direction (1) to ensure the reamer is taken down to the medial wall.

Direct the second reamer and all subsequent reamers in approximately 45° of abduction and 20° of anteversion for final position of the acetabular component (2).

Preserve subchondral bone to provide good support for the prosthesis. This might mean the reamer will not be medialized all the way to the inner wall. One might suggest leaving some remaining subchondral bone and removing the medial bone that is osteophyte and is covering fatty tissue.

Frequently palpate the posterior and anterior walls of the acetabulum during the reaming process as these walls will determine the largest acetabular size that can be accommodated. Avoid allowing the reamer to drift posteriorly where the bone might be less dense and the path of least resistance for the reamer.

To press-fit an R3™ acetabular shell the acetabulum can either be under-reamed by 1mm or may be reamed line-to-line depending on the bone quality and size of the acetabulum.

Acetabular reaming

5

Surgical tips:

• Each successive reamer must be fully seated within the acetabulum. Failure to do so will result in lateralization of the trial and exposure of the porous coating. If lateralization occurs, go back to a smaller reamer and begin again, checking each size to ensure that the reamers are fully seated.

• Increasing the reamer size by 2mm is recommended, although in smaller patients 1mm increments may be preferred.

• Mark the medial wall with an electrocautery prior to using the last reamer. If the last reamer does not remove the mark, repeat reaming, dropping back a size if necessary.

Instrument tips:

• The acetabular reamer has an open back, which helps visualize reaming and allows easy access to bone chips. This style of reamer is hemispherical and when fully seated it should be covered by the rim of the acetabulum.

• Gently rock reamer handle back and forth approximately 5° for last size used only to ensure rim is accurate for the desired press-fit.

6

After preparing the acetabulum, the trial shell should be inserted to verify size and position of the cup. The surgeon should note the appropriate orientation of the acetabular trial to position the cup correctly.

A trial liner insert cannot be inserted into a trial shell for trial reduction.

If trial reduction using a trial insert is desired at this time, then the preparation of the femur should occur up until the trial reduction stage. The surgeon then has the option of inserting a trial acetabular liner (preferred) in the acetabular implant for subsequent leg length, offset and stability assessments or the real acetabular insert.

Acetabular trialing

Surgical tip:

• The bone at the edge of the trial shell can be marked with an electrocautery to help in final component positioning.

Instrument tip:

• The trial shells are the exact size specified. They can be used to assess the accuracy of reaming or can be press-fit into the acetabulum if using a larger size than the final reamer.

7

Select the appropriate acetabular implant, attach the shell to the cup positioner/impactor and insert it into the acetabulum.

Rotate the X-Bar shaft so that it is in line with the liner removal slot. For the THREE HOLE cup, this positions the three holes in the superior direction. When implanting a MULTI HOLE shell, future access to the liner removal slot should be considered.

Position the X-Bar so that the vertical bar is perpendicular to the long axis of the body and the appropriate crossbar (left or right) aligns with the long axis of the body.

Firmly tap the inserter with a mallet until the cup is fully seated.

Gently toggle the impactor handle to assess the stability and contact of the shell.

Remove the X-Bar, then disengage the impactor handle and look through the impactor hole to judge the distance between the medial wall and the shell.

If the cup is firmly seated, there should be no gap between the shell and the medial wall and no apparent movement in the component.

Acetabular shell insertion

Surgical tips:

• The change in pitch that occurs as the shell is seated against the medial wall is often audible. A depth gauge can be inserted through the screw holes and apex hole to determine the adequacy of shell seating.

• Close attention should be paid to initial positioning of the R3™ shell. However, the use of the slap hammer may be helpful in extracting the shell for repositioning.

Instrument tips:

• The plastic tip on the cup impactor is removable for cleaning, or replacement if damaged.

• The X-Bar references 45° of abduction and 20° of anteversion .

8

Screw fixation is simple, fast and the most common method of assuring additional fixation. Acetabular screws work in compression, which allows the shell to fully seat in the acetabular cavity.

For screw fixation, each screw hole must be predrilled. Using the variable angle drill guide, adjust the angle of the tip to align with the selected screw hole and press firmly in the shell. After drilling the hole, use the depth gauge to verify appropriate screw length(s).

Use the screw forceps to hold the screw. Attach the ball-joint or flexible screwdriver shaft to the end of the screw. Then introduce the screw into the hole and screw it into place using the ratcheting screwdriver handle. Make sure the screw is fully seated within the screw hole so that it will not impinge on the acetabular shell/liner.

Acetabular screw insertion

Surgical tip:

• Screws have been shown to be a reliable method of assuring fixation; however, it is important to avoid neurovascular complications by proper screw placement, avoiding the anterior/superior or anterior/inferior quadrants.

9

A trial reduction should be performed with the final shell and broach in place to appropriately assess head length, stem offset, liner style and position. With XLPE liners, use of ‘skirted’ modular heads should be avoided when possible to maximize range of motion.

Before inserting the R3 acetabular liner, lavage any unused holes and insert the hole covers, if desired. Using the angled hole cover inserter, place screw hole covers over any remaining screw holes and then impact with the peg impactor. Cover the apex hole with the threaded hole cover. Using the straight screwdriver, screw in the hole cover until it stops and is flush with the inner diameter of the shell.

For XLPE liner insertion, screw the appropriate sized liner impactor head on the end of the cup impactor handle and ensure that the tabs on the liner are aligned with the indentions in the shell. Ensure all soft tissue and osteophytes have been removed from the periphery of the shell to avoid interference with the liner lock.

Wipe the shell ID with a lap sponge or gauze until clean and dry. Press the liner impactor firmly until liner is partially locked. Then use light, repetitive impacts with the mallet until the liner is fully seated.

Inspect the liner/shell interface for proper seating. The liner should sit flush with the face of the shell.

R3™ acetabular liner insertion

Surgical tips:

• Running a finger around the circumference of the shell and a visual check will help determine if the liner is flush with the shell face.

• The XLPE liner requires an impaction force between 60 and 120 pounds, increasing with the diameter of the shell.

• The XLPE liner can be removed and repositioned once without compromising the locking mechanism of the liner. To remove R3 liners, insert the liner removal tool fully into the removal slot and pry or impact the liner loose.

Instrument tips:

• The liner trials are designed with flexible locking tabs around the periphery that is a quick-snap design. Align tabs with indentions and snap into position. Do not force trial. The trial liners are removed with the trial liner removal tool via the removal slot at the apex of the trial liner and a clockwise twist of the removal tool.

10

XLPECups 22 28 32 36 40 44404244464850525456586062646668707274767880

Shell and liner offerings

11

Poly thickness chart

Shell OD Poly ID

Poly Thickness Taper Region mm

Poly Thickness Load- Bearing Region mm

40 22 5.5 6.142 22 6.5 7.144 22 7.5 8.146 28 5.4 6.148 28 6.4 7.148 32 4.3 5.150 28 7.3 8.150 32 5.3 6.152 28 8.3 9.152 32 6.3 7.152 36 4.3 5.154 28 9.3 10.154 32 7.3 8.154 36 5.3 6.156 28 10.3 11.156 32 8.3 9.156 36 6.3 7.156 40 4.6 5.058 28 11.3 12.158 32 9.3 10.158 36 7.3 8.158 40 5.3 6.060 28 12.3 13.160 32 10.3 11.160 36 8.3 9.160 40 6.5 7.060 44 4.3 5.0

Shell OD Poly ID

Poly Thickness Taper Region mm

Poly Thickness Load- Bearing Region mm

62 32 11.3 12.162 36 9.3 10.162 40 7.5 8.062 44 5.3 6.064 36 10.3 11.164 40 8.4 9.064 44 6.4 7.066-70 36 11.3 12.166-70 40 9.3 10.066-70 44 7.2 8.072-74 36 13.8 14.072-74 40 11.8 12.072-74 44 9.8 10.076-80 36 15.8 16.076-80 40 13.8 14.076-80 44 11.8 12.0

Taper region

Load-bearing

12

Catalog

R3™ NO HOLE Acetabular ShellsStandard size shells Small size shellsCat. no. ODmm Cat. no. ODmm7133-1846 46 7133-1840 407133-1848 48 7133-1842 427133-1850 50 7133-1844 447133-1852 527133-1854 54 Large size shells7133-1856 56 Cat. no. ODmm7133-1858 58 7133-1866 667133-1860 60 7133-1868 687133-1862 627133-1864 64

R3 THREE HOLE Acetabular ShellsStandard size shells Small size shellsCat. no. ODmm Cat. no. ODmm7133-5546 46 7133-5540 407133-5548 48 7133-5542 427133-5550 50 7133-5544 447133-5552 527133-5554 54 Large size shells7133-5556 56 Cat. no. ODmm7133-5558 58 7133-5566 667133-5560 60 7133-5568 687133-5562 627133-5564 64

R3 MULTI HOLE Acetabular ShellsStandard size shells Large size shellsCat. no. ODmm Cat. no. ODmm7133-8663 48 7133-8673 667133-8664 50 7133-8674 687133-8665 52 7133-8675 707133-8666 547133-8667 56 Jumbo size shells7133-8668 58 Cat. no. ODmm7133-8669 60 7133-8676 727133-8671 62 7133-8677 747133-8672 64 7133-8678 76

7133-0009 787133-0010 80

13

R3™ XLPE Acetabular Liners

ID OD0° XLPE linerCat. no.

20° XLPE linerCat. no.

0° +4 XLPE liner Cat. no.

20°+4 XLPE linerCat. no.

22 40 7133-4840 7133-4940 7133-5840 7133-714022 42 7133-4842 7133-4942 7133-5842 7133-714222 44 7133-4844 7133-4944 7133-5844 7133-7144

28 46 7133-7546 7133-4946 7133-5946 7133-774628 48 7133-7548 7133-4948 7133-5948 7133-774828 50 7133-7550 7133-4950 7133-5950 7133-775028 52 7133-7552 7133-4952 7133-5952 7133-775228 54 7133-7554 7133-4954 7133-5954 7133-775428 56 7133-7556 7133-4956 7133-5956 7133-775628 58 7133-7558 7133-4958 7133-5958 7133-775828 60 7133-7560 7133-4960 7133-5960 7133-7760

32 48 7133-9548 7133-7648 7133-6648 7133-7948

32 50 7133-9550 7133-7650 7133-6650 7133-7950

32 52 7133-9552 7133-7652 7133-6652 7133-795232 54 7133-9554 7133-7654 7133-6654 7133-795432 56 7133-9556 7133-7656 7133-6656 7133-795632 58 7133-9558 7133-7658 7133-6658 7133-795832 60 7133-9560 7133-7660 7133-6660 7133-796032 62 7133-9562 7133-7662 7133-6662 7133-7962

36 52 7133-2752 7133-5752 7133-6952 7133-855236 54 7133-2754 7133-5754 7133-6954 7133-855436 56 7133-2756 7133-5756 7133-6956 7133-855636 58 7133-2758 7133-5758 7133-6958 7133-855836 60 7133-2760 7133-5760 7133-6960 7133-856036 62 7133-2762 7133-5762 7133-6962 7133-856236 64 7133-2764 7133-5764 7133-6964 7133-856436 66-70 7133-0766 7133-1266 7133-1566 7133-266636 72-74 7133-8686 7133-8694 7133-8703 7133-871236 76-80 7133-1103 7133-1112 7133-1114 7133-8946

14

Catalog

R3™ XLPE Acetabular Liners (continued)

ID OD0° XLPE linerCat. no.

20° XLPE linerCat. no.

0° +4 XLPE liner Cat. no.

20°+4 XLPE linerCat. no.

40 56 7133-8679 7133-8687 7133-8695 7133-870440 58 7133-8680 7133-8688 7133-8696 7133-870540 60 7133-8681 7133-8689 7133-8697 7133-870640 62 7133-8682 7133-8690 7133-8698 7133-870740 64 7133-8683 7133-8691 7133-8699 7133-870840 66-70 7133-8684 7133-8692 7133-8701 7133-870940 72-74 7133-8685 7133-8693 7133-8702 7133-871140 76-80 7133-1094 7133-1104 7133-1113 7133-1116

44 60 7133-1096 7133-1106 7133-0011 7133-111844 62 7133-1097 7133-1107 7133-0012 7133-111944 64 7133-1098 7133-1108 7133-0013 7133-112144 66-70 7133-1099 7133-1109 7133-0014 7133-112244 72-74 7133-1101 7133-1110 7133-0016 7133-112344 76-78 7133-1102 7133-1111 7133-0017 7133-1124

15

R3™ Trial ShellsStandard size trial shells Small size trial shellsCat. no. ODmm Cat. no. ODmm7136-0745 45 7136-0739 397136-0746 46 7136-0740 407136-0747 47 7136-0741 417136-0748 48 7136-0742 427136-0749 49 7136-0743 437136-0750 50 7136-0744 447136-0751 517136-0752 52 Large size trial shells7136-0753 53 Cat. no. ODmm7136-0754 54 7136-0765 657136-0755 55 7136-0766 667136-0756 56 7136-0767 677136-0757 57 7136-0768 68

7136-0758 58 7136-6524 69

7136-0759 59 7136-6525 707136-0760 607136-0761 61 Jumbo size trial shells7136-0762 62 Cat. no. ODmm7136-0763 63 7136-6526 717136-0764 64 7136-6527 72

7136-6528 737136-6529 747136-6530 757136-6531 767136-2019 777136-2020 787136-2021 797136-2022 80

16

Catalog

R3™ Poly Trial Liners

ID OD0° XLPE trial linerCat. no.

20° XLPE trial linerCat. no.

0° +4 XLPE trial liner Cat. no.

20°+4 XLPE trial liner Cat. no.

22* 40 7136-0540 7136-5340 7136-6140 7136-8640

22* 42 7136-0542 7136-5342 7136-6142 7136-8642

22* 44 7136-0544 7136-5344 7136-6144 7136-8644

28 46 7136-9779 7136-9805 7136-9831 7136-985928 48 7136-9781 7136-9806 7136-9832 7136-986128 50 7136-9782 7136-9807 7136-9833 7136-986228 52 7136-9783 7136-9808 7136-9834 7136-986328 54 7136-9784 7136-9809 7136-9835 7136-986428 56 7136-9785 7136-9811 7136-9836 7136-986528 58 7136-9786 7136-9812 7136-9837 7136-986628 60 7136-9787 7136-9813 7136-9838 7136-9867

32 48 7136-9788 7136-9814 7136-9839 7136-986832 50 7136-9789 7136-9814 7136-9841 7136-986932 52 7136-9791 7136-9816 7136-9842 7136-987132 54 7136-9792 7136-9817 7136-9843 7136-987232 56 7136-9793 7136-9818 7136-9844 7136-987332 58 7136-9794 7136-9819 7136-9845 7136-987432 60 7136-9795 7136-9821 7136-9847 7136-987532 62 7136-9796 7136-9822 7136-9848 7136-9876

36 52 7136-9797 7136-9823 7136-9851 7136-987736 54 7136-9798 7136-9824 7136-9852 7136-987836 56 7136-9799 7136-9825 7136-9853 7136-987936 58 7136-9801 7136-9826 7136-9855 7136-988136 60 7136-9802 7136-9827 7136-9856 7136-988236 62 7136-9803 7136-9828 7136-9857 7136-988336 64 7136-9804 7136-9829 7136-9858 7136-988436* 66-70 7136-5266 7136-7966 7136-8566 7136-916636* 72-74 7136-6571 7136-6574 7136-6577 7136-658036* 76-80 7136-2312 7136-2314 7136-2316 7136-2318*Non-disposable trial liners

17

R3™ Poly Trial Liners

ID OD0° XLPE trial linerCat. no.

20° XLPE trial linerCat. no.

0° +4 XLPE trial liner Cat. no.

20°+4 XLPE trial liner Cat. no.

40* 56 7136-3420 7136-3422 7136-2030 7136-203540* 58 7136-2023 7136-2026 7136-2031 7136-203640* 60 7136-2024 7136-2027 7136-2032 7136-203740* 62 7136-3421 7136-2028 7136-2033 7136-203840* 64 7136-2025 7136-2029 7136-2034 7136-203940* 66-70 7136-6569 7136-6572 7136-6575 7136-657840* 72-74 7136-6570 7136-6573 7136-6576 7136-657940* 76-80 7136-2311 7136-2313 7136-2315 7136-2317

44* 60 7136-6081 7136-6094 7136-6087 7136-610144* 62 7136-6082 7136-6095 7136-6088 7136-610244* 64 7136-6083 7136-6096 7136-6089 7136-610344* 66-70 7136-6084 7136-6097 7136-6091 7136-610444* 72-74 7136-6085 7136-6098 7136-6092 7136-610544* 76-80 7136-6086 7136-6099 7136-6093 7136-6106*Non-disposable trial liners

R3 Liner Impactor HeadsCat. no. Size mm7136-6428* 287136-6432* 327136-6436* 367136-6438* 38-427136-6444* 44-487136-6451* 50-54*Exclusively for liner impaction

R3 MIS InstrumentsCat. no. Description7136-8569 Offset Shell Impactor7136-6052 Offset X-Bar7136-3077 Offset Impactor Tip7136-4073 Offset Reamer Handle

18

Catalog

R3™ Straight Shell ImpactorCat. no. 7136-4450

R3 Impactor Replacement TipCat. no. 7136-8570

R3 Depth GaugeCat. no. 7136-4451

X-BarCat. no. MT-2201

Screw ForcepsCat. no. 7136-2298

Ball Joint ScrewdriverCat. no. 7136-2295

R3 Variable Angle Drill GuideCat. no. 7136-4477

Reamer HandleCat. no. 7136-2279

Flexible Screw DrillsCat. no. Length mm7136-2915 157136-2925 257136-2935 357136-2950 50Captured Flexible Screwdriver ShaftCat. no. 7136-2291Captured U-Joint Screwdriver ShaftCat. no. 7136-2292R3 Surgical Templates sizes 40-68 (not shown)Cat. no. 7138-0666R3 Surgical Templates sizes 70-80 (not shown)Cat. no. 7138-1508

19

R3™ Trial Liner Removal ToolCat. no. 7136-4455

R3 Liner Removal ToolCat. no. 7136-6021

Hole Cover ImpactorCat. no. 73-2117

Trial Shell HandleCat. no. 7136-2297

Flexible ScrewdriverCat. no. 7136-2290

Ratchet HandleCat. no. 7136-2294

Small Slap HammerCat. no. 7136-7541

REFLECTION™ MalletCat. no. 7136-2106

Hole Cover InserterCat. no. 73-2133

Straight Screwdriver ShaftCat. no. 7136-2293

Power Adaptors (not shown)Cat. no. 7136-2781 7136-2782 7136-2783

20

Catalog

Reamer Domes Standard size Small sizeCat. no. Size mm Cat. no. Size mm7136-2742 42 7136-2738 387136-2743 43 7136-2739 397136-2744 44 7136-2740 407136-2745 45 7136-2741 417136-2746 467136-2747 47 Large size 7136-2748 48 Cat. no. Size mm7136-2749 49 7136-2765 657136-2750 50 7136-2766 667136-2751 51 7136-2767 677136-2752 52 7136-2768 687136-2753 53 7136-2769 697136-2754 54 7136-2770 707136-2755 55 7136-2771 717136-2756 56 7136-2772 727136-2757 57 7136-2773 737136-2758 58 7136-2774 747136-2759 59 7136-2775 757136-2760 60 7136-2776 767136-2761 61 7136-2777 777136-2762 62 7136-2778 787136-2763 63 7136-2779 797136-2764 64 7136-2780 80

21

R3™/REFLECTION™ Threaded Hole Cover Cat. no. 7133-6500

Spherical Head ScrewsCat. no. Length mm7133-2515 157133-2520 207133-2525 257133-2530 307133-2535 357133-2540 407133-2545 457133-2550 507133-2555 557133-2560 607133-2565 657133-2570 70

R3 Screw Hole CoverCat. no. 7136-9894

Small Outer CaseCat. no. 7112-9401 (not shown)Lid for Outer CaseCat. no. 7112-9402 (not shown)R3 Trial Shell TrayCat. no. 7136-2213 (not shown)R3 Jumbo Trial Liner Tray Cat. no. 7136-1076 (not shown)R3 Main Instrument TrayCat. no. 7136-2211 (not shown)R3 MIS Instrument Tray Cat. no. 7136-2219 (not shown)R3 Primary Reamer Dome TrayCat. no. 7136-2212 (not shown)R3 CDH Trial TrayCat. no. 7136-1077 (not shown)R3 Disposable Trial ToteCat. no. 7136-0656 (not shown)

22

Catalog

R3™ 0° 40mm Trial Liner TrayCat. no. 7136-0782R3 20° 40mm Trial Liner TrayCat. no. 7136-0783R3 0° +4 40mm Trial Liner TrayCat. no. 7136-0784R3 20° +4 40mm Trial Liner TrayCat. no. 7136-0786R3 0° and 20° 44mm Permanent Trial Liner Tray 60-70mmCat. no. 7136-6981R3 0° and 20° +4 44mm Permanent Trial Liner Tray 60-70mmCat. no. 7136-6982R3 0° and 20° +4 44mm Permanent Trial Liner Tray 72-80mmCat. no. 7136-6983

23

Indications

Contraindications

Hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis and diastrophic variant.

Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity.

The R3™ Acetabular System is for single use only and is intended for cementless use.

Caution: US Federal law restricts this device to sale by or on the order of a physician.

1 Conditions that would eliminate or tend to eliminate adequate implant support or prevent the use of an appropriately-sized implant, e.g.:

a Blood supply limitations

b Insufficient quantity or quality of bone support, e.g., osteoporosis or metabolic disorders which may impair bone formation and osteomalacia

c Infections, osteolysis or other conditions which lead to increased bone resorption

2 Mental or neurological conditions which tend to impair the patient’s ability or willingness to restrict activities

3 Physical conditions or activities which tend to place extreme loads on implants, e.g., Charcot joints, muscle deficiencies, multiple joint disabilities, etc.

4 Skeletal immaturity

5 The alumina ceramic liner is contraindicated for use with any product other than the metal shell with the correlating inner taper geometry and the appropriate sized alumina ceramic head. The alumina ceramic liner should only be used with the alumina ceramic head. In the US, refer to the separate package insert provided with the ceramic acetabular liners.

6 In revision surgery, inadequate proximal implant support is contraindicated. The literature shows an increased risk of implant failure in revision cases where proximal support is not achieved, poor bone quality exists, and smaller sized implants are utilized. The lower the implant fixation point in the femur (distance from the head center) the greater the risk of implant fracture and/or re-revision.

7 Morbid obesity.

Contraindications may be relative or absolute and must be carefully weighed against the patient’s entire evaluation and the prognosis for possible alternative procedures such as non-operative treatment, arthrodesis, femoral osteotomy, pelvic osteotomy, resection arthroplasty, hemiarthroplasty and others.

Conditions presenting increased risk of failure include: osteoporosis, metabolic disorders which may impair bone formation and osteomalacia.

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Telephone: 1-901-396-2121Information: 1-800-821-5700Orders and Inquiries: 1-800-238-7538

www.smith-nephew.com

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©2014 Smith & Nephew, Inc. All rights reserved.02272 V1 7138-1396 REVC 05/14